Clinical Study Report

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‌CLINICAL STUDY REPORT


1.0 TITLE PAGE



Study Title:

A Double Blind, randomized, single center, comparative, two-treatment, two-period, crossover, oral bioavailability study to determine the effect of MuscleBlaze Creatine Monohydrate (CreAMPT"’) as compared to Regular Creatine Monohydrate

(micronized) in adult healthy male subjects under fasting condition.


Investigational Product:

Test Product: MuscleBlaze Creatine Monohydrate (CreAMP)”' 3.1 gm [containing

micronized creatine monohydrate and l00ing CreabsorbT“'(Bright Life care proprietary formula)] manufactured by Bright Lifecare Pvt. Ltd.

Reference Product: Regular Creatine Monohydrate (micronized) 3.0 gm manufactured

by Bright Lifecare Pvt. Ltd.

Design:

A Double Blind, randomized, single center, comparative, two-treatment, two-sequence,

two-period, crossover, oral bioavailability study.


Sponsor:

Bright Lifecare Pvt. Ltd. (Healthkart)

The Presidency, Tower B, Second Floor, 46/4, M

G Road, Sector-14, Opp. Girls College, Gunigram, Haryana, 122001.

Protocol No.:

24-007

Phase of the Study:

Bioavailability Study

Study Initiation Date

05-SEP-2024

Study Completion Date

13-SEP-2024


Principal Investigator:

Dr. Anand Ashtekar, MBBS

Principal Investigator

Jindal Life Science Private Limited

Sponsor Representative:

Mr. Anupam Trehan Senior Vice President

Report Date

03-Dec-2024

Prepared By


Dr. Surya Teja Reddy Clinical Data Manager Aiit'iga Research Pvt Ltd


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Approved By


Manoj G

Karwa

Head — CT and PV Auriga Research Pvt.Ltd



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‌2.0 SYNOPSIS


Title of the Study: A Double Blind, randomized, single center, comparative, two-treatment, two-period, crossover, oral bioavailability study to determine the effect of MuscleBlaze Creatine Monohydrate (CreAMPTM) compared to Regular Creatine Monohydrate (micronized) in adult healthy male subjects

under fasting condition.

Investigator: Dr. Anand Ashtekar, MBBS

Study Centres (Clinical, Screening, Clinical Laboratory, PK and Statistical, Bioanalytical):

Clinical:

Jindal Life Science Pvt. Ltd.,

G1-338, RIICO Industrial Area, Phase-1 Sitapura, Jaipur- 302022, Rajasthan, India

Screening:

Jindal Life Science Pvt. Ltd.,

G1-338, RIICO Industrial Area, Phase-1 Sitapura, Jaipur- 302022, Rajasthan, India

Clinical Laboratory:

Dr. B LAL CLINICAL LAB PVT. LTD.

6-D, Malviya Nagar Industrial Area, Malviya Nagar, Jaipur, 302017, Rajasthan

Tel: +91-9929955677

PK and Statistical:

Auriga Research Private Limited

136, Sector 5, IMT Manesar, Gurugram,

Haryana 122050

GK Analytics

Plot No.118, 1st Floor, Lakshmi Narsimha Puran Colony, Hastinapuram-500079

Email: ravinndhra@gkanalytics.in

Bioanalytical:

City X-Ray & Scan Clinic Pvt. Ltd.

5A/34, Najafgarh Rd, near Haldiram Restaurant, Block 5A, Tilak Nagar, New Delhi, Delhi, 110018

Studied Period of Clinical Phase:

Phases of development

Period

Initiation

Completion

Clinical Phase

Period-I

05-Sep-2024

06-Sep-2024

Period-II

12-Sep-2024

13-Sep-2024

Bio analytical Phase

11-Oct-2024

18-Oct-2024


Development Phase of the Study:

Bioavailability Study

  • Objectives:

To assess the comparative bioavailability of MuscleBlaze Creatine Monohydrate (CreAMP) ™ compared to Regular Creatine Monohydrate (micronized)

To assess safety and tolerability of the subject to CreAMPTM.

Methodology:

Clinical personnel explained all study related procedures, duration, dates and timings, information on the study treatments and confidentiality of the subject’s data clearly to the subjects during the informed consent procedure. Subjects who signed the consent form and showed their willingness to participate in the study were enrolled. Subjects who were eligible when assessed against the inclusion and exclusion criteria and who were found to be healthy on physical examination with laboratory investigation values within reference limits were considered for admission to the study. Subjects whose pre-study laboratory values were outside the reference range were also considered for participation provided these values were considered clinically non-significant by the investigator. The eligible subjects reported to the study site on 05 Sep 2024 for period 01 and on 12 Sep 2024 for period 02. Treatments were allocated to subjects per the randomization schedule generated using statistical techniques with SAS® statistical software (Version: 9.4 or higher; SAS Institute Inc., USA). Blood samples were drawn before dosing (0.00 hours) and up to 06.00 hours after dosing in each period. Statistical analysis

performed using Phoenix® WinNonlin® Version 8.5.

Number of Subjects:

  • No. of subjects Planned: 32

  • No. of subjects dosed

    • Period I - 32

    • Period II- 30

  • No. of subjects discontinued: 02

  • No. of subjects completed: 30

  • No. of subjects analyzed: 30

    • No. of subjects included in pharmacokinetic and statistical analysis: 30

    • No. of subjects was analysed in the Bioanalytical laboratory for safety reasons: 30

Main criteria for Inclusion:

Healthy human male subjects within the age range of 18 to 50 years (both inclusive) with a body-mass index (BMI) of 18.5 kg/m² to 25.0 kg/m² (both inclusive) and a body weight was ≥ 50 kg, who had no clinically significant disease or clinically significant laboratory values, were included. Subjects who had

no medical history and normal physical examination during screening, and who complied with the


Name

:

CreAMP TM Micronized Creatine Monohydrate

Manufactured by

:

Bright Lifecare Pvt. Ltd.

Batch No.

:

JJECMCUF0001

Manufacturing Date

:

29/08/2024

Expiry Date

:

28/06/2026

Mode of Administration

:

Orally


Reference Product:

Name : Regular Micronized Creatine Monohydrate

Manufactured by : Bright Lifecare Pvt. Ltd.

Batch No. : JJECMCUF0001 (SG)

Manufacturing Date : 29/08/2024

Expiry Date : 28/06/2026

Mode of Administration : Orally

Duration of Treatment: Considering the minimum washout period, the expected study duration of clinical part is 09 days from the day of check-in of first period.

Pharmacokinetic Analysis:

  • Primary pharmacokinetic parameters: Cmax and AUC0-t

  • Secondary pharmacokinetic parameters: AUC0-inf, MRT, CL, Vz, Tmax , Kel, andt½.

  • Software: Phoenix® WinNonlin® Version 8.5

  • No. of subjects included in pharmacokinetic analysis: 30

TEST PRODUCT:

REFERENCE

PRODUCT:

PARAMETER

Mean ± SD

Mean ± SD

Cmax (mmol/L)

0.424 ± 0.090

0.359 ± 0.091

AUC0_t (hr*mmol/L)

1.362 ± 0.314

0.980 ± 0.207

AUCo_inf (hr*mmol/L)

2.303 ± 1.090

1.348 ± 0.349

Tmax (hr)

1.250 ± 0.626

1.067 ± 0.286

Kel (1/hr)

0.213 ± 0.086

0.253 ± 0.092

inclusion criteria, were eligible. Additionally, subjects who were able to read and understand the informed consent document and provided written informed consent to participate in the study were included.

Test Product T:



















t1/2 (hr)

4.306 ± 3.027

3.386 ± 2.340

Vz (g/(mmol/L)/kg)

15.828 ± 5.337

21.506 ± 9.279

CL (g/(hr*mmol/L)/kg)

3.072 ± 1.179

4.702 ± 1.122

MRT (hr)

2.527 ± 0.224

2.271 ± 0.152


The Cmax & Bioavailability enhancement have been shown as per the graphical representation below: Fig 1.1 , Fig 1.2, Fig 1.3

Fig 1.1


Fig 1.2 Fig 1.3

The difference between Test vs reference has been stated below graphical format for secondary parameters in Fig 1.4, Fig 1.5 ,Fig 1.6 & Fig 1.7

Fig 1.4 Fig 1.5


Fig 1.6 Fig 1.7


Conclusion:

This double-blind, randomized, single-center, two-treatment, two-period, crossover study evaluated the oral bioavailability and pharmacokinetic profile of MuscleBlaze Creatine Monohydrate (CreAMP™) compared to Regular Creatine Monohydrate (micronized) in healthy adult male subjects under fasting conditions. The primary objective was to explore whether the test product, CreAMP™, showed potential for improved bioavailability and peak plasma concentration relative to the reference product. .

Key Findings:

  • Enhanced Bioavailability and Peak Concentration:

    • The test product achieved an 18.10% higher peak plasma concentration than the reference product (Fig 1.1).

    • CreAMP™ demonstrated a 38.97% increase in bioavailability compared to regular creatine monohydrate (Fig 1.2).

  • Creatine Level Maintenance:

    • Both products-maintained creatine levels within normal physiological ranges across all time points, measured pre-dose and six hours post-dose.

  • Safety and Tolerability:

    • Both CreAMP™ and regular creatine monohydrate were well-tolerated, with no significant adverse events reported, highlighting a favorable safety profile.

      Pharmacokinetic Insights:

      The study revealed significant differences between the two products in key pharmacokinetic parameters, particularly those impacting dosing and creatine loading efficiency:

  • Total Creatine Exposure ( AUC 0-∞)

    • The 71% higher AUC₀-∞ for CreAMPTM (Fig 1.3) compared to regular creatine monohydrate demonstrates significantly increased total creatine exposure in the body.


This enhanced systemic availability ensures a more efficient supply of creatine to support muscle energy, strength, and recovery.

  • Half-Life:

    • CreAMP™ (Product A) exhibited a longer half-life (4.31 hours), which was 21.37% higher than regular creatine monohydrate (3.39 hours) (Fig 1.4).This prolonged half-life supports sustained plasma creatine levels, reducing dosing frequency during the loading phase.

  • Clearance and Distribution:

    • CreAMP™ showed a 34.67% lower clearance rate (Fig 1.7) and a 26.40% reduced volume of distribution (Fig 1.6), indicating less elimination. This allows more creatine to remain available for uptake.

  • Elimination and Mean Residence Time:

    • CreAMP™ demonstrated a 15.81% lower elimination rate constant (Kel) ( Fig 1.5) and a 10.13% higher mean residence time (MRT) (Fig 1.7), prolonging its duration of action and enhancing creatine accumulation efficiency.

  • Implications for Creatine Supplementation:

  • The pharmacokinetic profile of CreAMP™ suggests it requires a lower total loading dose or fewer administrations to achieve optimal muscle creatine saturation, offering greater convenience and efficiency for users.

  • Implications for performance

    • Data showing enhanced bioavailability of creatine monohydrate suggests a potential for improved delivery to the body, which may influence exercise performance, muscle strength, and lean muscle mass.

    • Findings on improved absorption indicate a possible contribution to strength and power output during high-intensity exercise.

    • Evidence of increased creatine uptake with advanced formulations highlights its role in fueling muscles for activities requiring strength, speed, and endurance.

    • Observed higher availability of creatine molecules aligns with potential benefits for supporting muscle strength, mass, and recovery

CreAMP™ significantly outperformed regular creatine monohydrate in bioavailability and peak plasma concentration, supported by a favorable safety profile and superior pharmacokinetics. These attributes make CreAMP™ a potentially more effective and user-friendly option for optimized creatine supplementation.

Date of Report: 03-DEC-2024